Change in neck vein flow after chronic cerebro-spinal venous insufficiency (CCSVI) therapy in patients with multiple sclerosis
| ISRCTN | ISRCTN24087468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24087468 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/03/2011
- Registration date
- 10/06/2011
- Last edited
- 10/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Raj Attariwala
Scientific
Scientific
1371 West Broadway
Vancouver
V6H 1G9
Canada
| Phone | +1 604 733 4007 |
|---|---|
| rattariwala@aimmedicalimaging.com |
Study information
| Study design | Single centre observational longitudinal case control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pulsed short magnetic resonance imaging (MRI) to quantify neck vascular flow changes after jugular venous dilation (venoplasty) in patients with multiple sclerosis |
| Study objectives | Venous narrowing and thus reduction in jugular vein flow has recently been implicated as a potential contributing factor in Multiple Sclerosis. Jugular venoplasty has been hypothesised to improve jugular venous drainage, and thus improve the symptoms of patients suffering with multiple sclerosis. Many patients have had magnetic resonance imaging (MRI) examinations assessing neck vein and arterial blood flow prior to venoplasty. The aim of this observational study is to use MRI scans to compare the the change in the blood flow in the neck vessels of patients after jugular veinoplasty with their pre-procedural flow measurements |
| Ethics approval(s) | Not provided at time of registration - IRB Services approval pending as of 31/03/2011 |
| Health condition(s) or problem(s) studied | Multple sclerosis/ diagnostic imaging |
| Intervention | Observations: 1. MRI flow quantification will be used to measure blood flow rate averaged over 2 minutes within the right and left internal jugular veins 2. At the same level within the upper neck, left and right arterial blood flow will be measured 3. A ratio of total jugular vein to arterial blood flow will be calculated, and compared to the same measurements and site obtained on pre-procedural MRI scans 4. The change in percentage blood flow will be statistically analysed using the paired t-test Patients will be provided with a questionnaire form to assess for quality of life changes at the time of the study. This questionnaire includes the following questions: 1. Date and location of CCSVI treatment (venoplasty) 2. Age of diagnosed MS 3. Age of suspected onset, type of MS, current medication, iron chelation or naturopathic treatments, vitamin D supplements 4. Effects pre and post therapy: 4.1. Cold extremities (pre/post) 4.2. Brain fog (pre/post) 4.3. Head fullness (pre/post) 4.4. Fatiguability (hrs of productivity) (pre/post) 4.5. Exercise tolerance (pre/post) 4.6. Colorperception/vision change (post) 4.7. Taste/smell change (post) 4.8. Hearing change (post) 4.9. Temperature tolerance (pre/post) 4.10. Bowel/bladder incontinence change (pre/post) |
| Intervention type | Other |
| Primary outcome measure | Paired t-test statistical analysis will be used to assess for significance |
| Secondary outcome measures | Questionnaire answers will be tabulated to assess for change |
| Overall study start date | 01/04/2011 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Pilot study of 25-50 participants |
| Key inclusion criteria | 1. Above 19 years of age 2. Has been diagnosed with multiple sclerosis 3. Has an MRI of the neck veins with flow quantification prior to having jugular venoplasty (CCSVI treatment) within the past 1 year |
| Key exclusion criteria | 1. Patients who have a contraindication to MRI scan 2. Patients with metal implants such as: 2.1. In the eye 2.2. Non-MRI compatible stents 2.3. Staples |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
1371 West Broadway
Vancouver
V6H 1G9
Canada
V6H 1G9
Canada
Sponsor information
AIM Medical Imaging (Canada)
Hospital/treatment centre
Hospital/treatment centre
1371 West Broadway
Vancouver
V6H 1G9
Canada
| Phone | +1 604 733 4007 |
|---|---|
| appointments@aimmedicalimaging.com | |
| Website | http://www.aimmedicalimaging.com |
Funders
Funder type
Hospital/treatment centre
AIM Medical Imaging (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
